Comparative Efficacy of Physiotherapeutic Exercise Regimens Implemented After Caudal Epidural Steroid Injection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in Pain Intensity (Numeric Rating Scale, 0-10)
研究概览
简要总结
**Brief Summary**
Lumbar radicular pain arising from intervertebral disc herniation is commonly managed with a caudal epidural steroid injection (CESI), a minimally invasive procedure that delivers anti-inflammatory medication to the sacral hiatus. Although CESI affords short-term analgesia, a sizable proportion of patients continue to experience pain-related disability and diminished quality of life, underscoring the need for optimised post-injection rehabilitation.
This single-centre, three-arm, parallel-group randomised controlled trial will evaluate the comparative efficacy of two evidence-informed exercise paradigms-moderate-intensity aerobic training and progressive lumbopelvic stabilisation-when each is superimposed upon a standard physiotherapy package of heat, therapeutic ultrasound and transcutaneous electrical nerve stimulation (TENS). Forty-two adults (18-70 years) with MRI-confirmed lumbar disc herniation who have undergone CESI at Çankırı State Hospital will be randomly allocated (1:1:1) to one of the following six-week interventions, initiated two weeks post-injection and delivered thrice weekly under physiotherapist supervision:
- Conventional physiotherapy alone (heat + ultrasound + TENS).
- Conventional physiotherapy plus aerobic exercise (treadmill walking at 55-80 % of age-predicted maximal heart rate with structured warm-up/cool-down).
- Conventional physiotherapy plus core-stabilisation exercise (phased activation of deep trunk musculature progressing to dynamic tasks on unstable surfaces).
Primary end-points are pain intensity (10 cm Visual Analogue Scale) and back-specific disability (Oswestry Disability Index). Secondary end-points include generic health-related quality of life (SF-12) and lumbar proprioceptive body awareness (Fremantle Back Awareness Questionnaire). Outcomes will be captured at baseline, post-intervention (6 weeks) and at 3- and 6-month follow-up to ascertain both immediate and sustained effects.
Study Question Does adjunctive aerobic or core-stabilisation exercise confer superior reductions in pain and disability, and greater gains in quality of life and body awareness, compared with conventional physiotherapy alone in adults following CESI for lumbar disc herniation?
It is hypothesised that both exercise approaches will yield clinically and statistically superior outcomes relative to standard care, with stabilisation training providing the most durable functional benefits. Findings are expected to refine post-CESI rehabilitation algorithms and inform evidence-based clinical guidance for physiotherapists managing lumbar disc pathology.
详细描述
Scientific Rationale and Background Caudal epidural steroid injection (CESI) is widely employed to attenuate lumbosacral radicular pain by delivering glucocorticoids into the sacral hiatus, thereby diminishing local biochemical inflammation around the affected nerve roots. While CESI frequently yields rapid analgesia, pain recurrence and activity limitation are common within three to six months, indicating that pharmacological attenuation of inflammation alone is insufficient to restore neuromuscular control and functional capacity. Emerging evidence suggests that structured exercise commenced shortly after CESI can exploit the "analgesic window" to retrain motor patterns, enhance spinal stability, and improve cardiovascular fitness-yet the optimal exercise paradigm remains unclear. Aerobic conditioning may promote anti-inflammatory myokine release and general de-conditioning reversal, whereas lumbopelvic stabilisation targets segmental control deficits and proprioceptive impairment-both recognised contributors to chronicity in lumbar disc pathology.
Study Design and Setting This is a single-centre, prospective, three-arm, parallel-group, superiority randomised controlled trial conducted at the Department of Physiotherapy, Çankırı State Hospital, Türkiye. Allocation (1:1:1) is computer-generated with permuted blocks of variable size; assignments are sealed in sequentially numbered opaque envelopes by an independent statistician to ensure allocation concealment. Outcome assessors and data analysts are blinded to group assignment. Interventions are delivered in a dedicated physiotherapy gymnasium under the supervision of senior musculoskeletal physiotherapists trained in study procedures.
Intervention Logic
Each participant receives a two-week "wash-in" period following CESI to permit stabilisation of acute pharmacodynamic effects. Thereafter, three arms are implemented over six weeks (18 supervised sessions):
- Conventional Physiotherapy (control) - superficial moist heat (20 min, 70 °C hydrocollator packs), continuous ultrasound (1 MHz, 1.0 W cm-², 5 min), and biphasic TENS (100 Hz, 100 µs, 20 min).
- Conventional Physiotherapy + Aerobic Exercise - identical modality package followed by treadmill walking at 55-80 % age-predicted HR_max with 5 min warm-up, 10-25 min load (weekly 5 % progression), and 5 min cool-down. Heart rate is telemetrically monitored; intensity is titrated using the Borg CR-10 scale and Tanaka equation (208-0.7·age).
- Conventional Physiotherapy + Core-Stabilisation Exercise - modality package followed by a phased stabilisation protocol:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The treating physiotherapists and participants cannot be blinded because the nature of the exercise programmes is overt. However, (i) outcome assessors who perform all baseline and follow-up measurements and (ii) the trial statistician responsible for primary analyses will remain unaware of group allocation. Randomisation codes are stored in sealed, opaque envelopes by a study coordinator not involved in assessment or analysis, and participants are reminded not to disclose their exercise group during evaluations.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years.
- •MRI-confirmed lumbar intervertebral disc herniation.
- •Has received a caudal epidural steroid injection (CESI) within the past 2 weeks at Çankırı State Hospital.
- •Low-back or leg pain intensity ≥ 3 cm on a 10-cm Visual Analogue Scale after the injection.
- •Medically cleared for moderate aerobic and core-stabilisation exercise (no cardiac or orthopaedic contraindications).
- •Able to attend supervised physiotherapy three times per week for six weeks.
- •Willing and able to give written informed consent and to comply with study procedures.
- •Sufficient Turkish literacy (minimum primary-school education) to complete questionnaires.
排除标准
- •Uncontrolled systemic disease (e.g., poorly controlled diabetes mellitus, congestive heart failure, active hepatitis C or other significant liver disease).
- •Neurological red flags such as myelopathy or cauda equina syndrome.
- •Previous lumbar spine surgery at the affected disc level.
- •Current pregnancy or planning pregnancy during the study period.
- •Severe musculoskeletal, cardiovascular, or respiratory condition that precludes safe exercise participation.
- •Use of systemic corticosteroids or opioid analgesics that cannot be stabilised for the duration of the trial.
- •Ongoing litigation or workers' compensation claim related to low-back pain.
- •Inability to communicate effectively with study staff or to follow instructions.
研究组 & 干预措施
Conventional Physiotherapy
Other: Conventional Physiotherapy (moist heat, therapeutic ultrasound, TENS)
干预措施: Conventional Physiotherapy (Other)
Aerobic Exercise + Conventional Physiotherapy
- Behavioral: Aerobic Exercise (treadmill walking)
- Other: Conventional Physiotherapy
干预措施: Conventional Physiotherapy (Other)
Aerobic Exercise + Conventional Physiotherapy
- Behavioral: Aerobic Exercise (treadmill walking)
- Other: Conventional Physiotherapy
干预措施: Aerobic Exercise Programme (Behavioral)
Core-Stabilization Exercise + Conventional Physiotherapy
- Behavioral: Core-Stabilisation Exercise
- Other: Conventional Physiotherapy
干预措施: Conventional Physiotherapy (Other)
Core-Stabilization Exercise + Conventional Physiotherapy
- Behavioral: Core-Stabilisation Exercise
- Other: Conventional Physiotherapy
干预措施: Core-Stabilization Exercise Programme (Behavioral)
结局指标
主要结局
Change in Pain Intensity (Numeric Rating Scale, 0-10)
时间窗: Baseline; 6 weeks; 3 months; 6 months
Unit of Measure: points on a 0-to-10 scale Description: 11-point Numeric Rating Scale; 0 = no pain, 10 = worst imaginable pain. Change from baseline will be calculated at each follow-up. Higher scores indicate worse pain.
次要结局
- Change in Disability (Oswestry Disability Index, 0-100)(Baseline, 6 weeks, 3 months, 6 months)
- Change in Health-Related Quality of Life (SF-12 Physical Component, 0-100)(Baseline, 6 weeks, 3 months, 6 months)
- Change in Health-Related Quality of Life (SF-12 Mental Component, 0-100)(Baseline; 6 weeks; 3 months; 6 months)
- Change in Lumbar Body Awareness (Fremantle Back Awareness Questionnaire, 0-36)(Baseline; 6 weeks; 3 months; 6 months)
- Return-to-Work Days(Up to 6 months)
研究者
Ceyhun Türkmen
Assoc. Prof. Dr.
Çankırı Karatekin University